Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Class Implantable

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EyeMax2 Regular 20/Pack (Italian Label)
MAXTEC, LLC
Regular
In Commercial Distribution

  • 00817770025832 ()
R300P01-004

  • Phototherapy infant blanket
CS100 Intra-Aortic Balloon Pump, Italian, 220V
Datascope Corp.
0998-00-3013-67
Not in Commercial Distribution

  • 10607567107486 ()
0998-00-3013-67

  • Intra-aortic balloon pump
CS100 Accessory Kit, Italian, 220 V
Datascope Corp.
0020-00-0463-07
Not in Commercial Distribution

  • 10607567112626 ()
0020-00-0463-07

  • Intra-aortic balloon pump
CS300 Intra-Aortic Balloon Pump, Italian, 220V
Datascope Corp.
0998-00-3023-67
In Commercial Distribution

  • 10607567112619 ()
0998-00-3023-67

  • Intra-aortic balloon pump
CS300 Accessory Kit, Italian, 220 V
Datascope Corp.
0020-00-0482-07
In Commercial Distribution

  • 10607567108476 ()
0020-00-0482-07

  • Intra-aortic balloon pump
Night Shift LE Device Kit - Italian
ADVANCED BRAIN MONITORING, INC.
NS27-1005.LE(ITA)
In Commercial Distribution

  • 60850015266197 ()


  • Behavioural therapy electrical stimulation system
Italian Cypress -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386079
In Commercial Distribution

  • 00630414965963 ()
T23L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
KIT ITALIAN LENS INTEGRATED SYSTEM NON-WIFI
Smith & Nephew, Inc.
72204897
In Commercial Distribution

  • 00885556618073 ()
72204897

  • Endoscopic video imaging system
S&N 400 INSUFFLATOR KIT ITALIAN
Smith & Nephew, Inc.
7209943
In Commercial Distribution

  • 00885554011821 ()
7209943

  • Laparoscopic insufflator
No Description
Respironics Novametrix, LLC
7900
In Commercial Distribution

  • 00884838015654 ()
1060460

  • Monitoring spirometer, electrical
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